BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 9730887 · Received February 19, 2020

    Report

    Report Number
    2125050-2020-00114
    Event Type
    Injury
    Date Received
    February 19, 2020
    Report Date
    January 30, 2020
    Product Code
    FHW
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS CREATED AS A FOLLOW-UP TO RECORD (B)(4), INITIALLY REPORTED ON PRODUCT CODE FHW ASR EXEMPTION # E2006011 FOR JULY-SEPTEMBER 2017. THIS MDR IS TO REFLECT THE ADDITIONAL INFORMATION TO BE ADDED TO THE "INTIAL" ASR REPORT.

    Description of Event or Problem · 1

    THIS MDR IS CREATED AS A FOLLOW-UP TO RECORD (B)(4), INITIALLY REPORTED ON PRODUCT CODE FHW ASR EXEMPTION # E2006011 FOR JULY-SEPTEMBER 2017. THIS MDR IS TO REFLECT THE ADDITIONAL INFORMATION TO BE ADDED TO THE INTIAL ASR REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHICH STATED THAT THE PATIENT INDICATED THAT THE PHYSICIAN WAS NOTIFIED THAT THE DEVICE WAS AUTO INFLATING AT HIS FIRST POST-OPERATIVE APPOINTMENT ON MAY 15, 2015. DURING THE PERIOD LEADING UP TO THE PATIENT'S NEXT APPOINTMENT ON (B)(6) 2015, THE PATIENT WAS REQUIRED TO TAKE OPIOIDS FOR PAIN RELIEF. THE PATIENT'S ATTEMPTS TO INFLATE THE CYLINDERS AS DIRECTED WERE UNSUCCESSFUL AS THE PUMP WOULD NOT COMPRESS, EVEN WITH MUCH FORCE. THE PATIENT DID GET THE PUMP TO COMPRESS WHEN HE SQUEEZED THE RELEASE VALVE AT THE SAME TIME, BUT THE CYLINDERS WOULD NOT INFLATE WHEN DOING THIS. THE PATIENT STATED THE PHYSICIAN OBSERVED THE AUTO INFLATION AND CONFIRMED THE PUMP WOULD NOT COMPRESS UNLESS THE RELEASE VALVE WAS USED SIMULTANEOUSLY. THE AUTO INFLATION AND RESULTING PAIN CONTINUED THROUGH THE PATIENT'S NEXT APPOINTMENTS ON (B)(6) 2015 AND (B)(6) 2015. THE PATIENT STATED HE EXPERIENCED ADDITIONAL INCONVENIENCE, INTERRUPTED SLEEP, INABILITY TO ENGAGE IN NORMAL ACTIVITIES AND INABILITY TO USE THE DEVICE AS INTENDED. AT THE (B)(6) 2015 APPOINTMENT THE PHYSICIAN RECOMMENDED, AND PATIENT AGREED, TO A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187995 INFLATABLE PENILE PROSTHESIS FHW

    Patients

    Seq Age Sex Outcome Treatment
    1